Number of Files: 354 Number of Subfolder: 370

NeeS report v2.9

x / x / x / x / x / x / x / x
grouping
| / FR-H-1122-05
x / M / | / | / 0000
x / M / | / | / | / m1
x / | / | / | / | / eu
x / | / | / | / | / | / 10-cover
x / | / | / | / | / | / | / be
x / | / | / | / | / | / | / | / be-cover-var.pdf (8Kb)
x / | / | / | / | / | / 110-paediatrics
x / | / | / | / | / | / | / paediatrics-var.pdf (8Kb)
x / | / | / | / | / | / 12-form
x / | / | / | / | / | / | / be
x / | / | / | / | / | / | / | / be-form-var.pdf (8Kb)
x / | / | / | / | / | / 13-pi
x / | / | / | / | / | / | / 131-spclabelpl
x / | / | / | / | / | / | / | / be
x / | / | / | / | / | / | / | / | / de
x / | / | / | / | / | / | / | / | / | / be-impack-10mgdec06.pdf (7Kb)
x / | / | / | / | / | / | / | / | / | / be-interpack-10mgdec06.pdf (7Kb)
x / | / | / | / | / | / | / | / | / | / be-outer-10mgdec06.pdf (7Kb)
x / | / | / | / | / | / | / | / | / | / be-pl-10mgdec06.pdf (7Kb)
x / | / | / | / | / | / | / | / | / fr
x / | / | / | / | / | / | / | / | / | / be-impack-10mgdec06.pdf (7Kb)
x / | / | / | / | / | / | / | / | / | / be-interpack-10mgdec06.pdf (7Kb)
x / | / | / | / | / | / | / | / | / | / be-outer-10mgdec06.pdf (7Kb)
x / | / | / | / | / | / | / | / | / | / be-pl-10mgdec06.pdf (7Kb)
x / | / | / | / | / | / | / | / | / | / be-spc-combineddec06.pdf (7Kb)
x / | / | / | / | / | / | / | / | / nl
x / | / | / | / | / | / | / | / | / | / be-impack-10mgdec06.pdf (7Kb)
x / | / | / | / | / | / | / | / | / | / be-interpack-10mgdec06.pdf (7Kb)
x / | / | / | / | / | / | / | / | / | / be-outer-10mgdec06.pdf (7Kb)
x / | / | / | / | / | / | / | / | / | / be-pl-10mgdec06.pdf (7Kb)
x / | / | / | / | / | / | / | / | / | / be-spc-combineddec06.pdf (7Kb)
x / | / | / | / | / | / | / | / common
x / | / | / | / | / | / | / | / | / en
x / | / | / | / | / | / | / | / | / | / common-impack-10mgdec06.pdf (7Kb)
x / | / | / | / | / | / | / | / | / | / common-interpack-10mgdec06.pdf (7Kb)
x / | / | / | / | / | / | / | / | / | / common-outer-10mgdec06.pdf (7Kb)
x / | / | / | / | / | / | / | / | / | / common-pl-10mgdec06.pdf (7Kb)
x / | / | / | / | / | / | / | / | / | / common-spc-combineddec06.pdf (7Kb)
x / | / | / | / | / | / | / 132-mockup
x / | / | / | / | / | / | / | / be
x / | / | / | / | / | / | / | / | / be-mockup-var.pdf (8Kb)
x / | / | / | / | / | / | / 133-specimen
x / | / | / | / | / | / | / | / be
x / | / | / | / | / | / | / | / | / be-specimen-var.pdf (8Kb)
x / | / | / | / | / | / | / 134-consultation
x / | / | / | / | / | / | / | / be
x / | / | / | / | / | / | / | / | / be-consultation-var.pdf (8Kb)
x / | / | / | / | / | / | / 135-approved
x / | / | / | / | / | / | / | / be
x / | / | / | / | / | / | / | / | / be-approved-var.pdf (8Kb)
x / | / | / | / | / | / | / 136-braille
x / | / | / | / | / | / | / | / braille-var.pdf (8Kb)
x / | / | / | / | / | / 14-expert
x / | / | / | / | / | / | / 141-quality
x / | / | / | / | / | / | / | / quality-var.pdf (8Kb)
x / | / | / | / | / | / | / 142-nonclinical
x / | / | / | / | / | / | / | / nonclinical-var.pdf (8Kb)
x / | / | / | / | / | / | / 143-clinical
x / | / | / | / | / | / | / | / clinical-var.pdf (8Kb)
x / | / | / | / | / | / 15-specific
x / | / | / | / | / | / | / 151-bibliographic
x / | / | / | / | / | / | / | / bibliographic-var.pdf (8Kb)
x / | / | / | / | / | / | / 152-generic-hybrid-bio-similar
x / | / | / | / | / | / | / | / biosimilar-var.pdf (8Kb)
x / | / | / | / | / | / | / | / generic-var.pdf (8Kb)
x / | / | / | / | / | / | / | / hybrid-var.pdf (8Kb)
x / | / | / | / | / | / | / 153-data-market-exclusivity
x / | / | / | / | / | / | / | / datamarketexclusivity-var.pdf (8Kb)
x / | / | / | / | / | / | / 154-exceptional
x / | / | / | / | / | / | / | / exceptional-var.pdf (8Kb)
x / | / | / | / | / | / | / 155-conditional-ma
x / | / | / | / | / | / | / | / conditionalma-var.pdf (8Kb)
x / | / | / | / | / | / 16-environrisk
x / | / | / | / | / | / | / 161-nongmo
x / | / | / | / | / | / | / | / nongmo-var.pdf (8Kb)
x / | / | / | / | / | / | / 162-gmo
x / | / | / | / | / | / | / | / gmo-var.pdf (8Kb)
x / | / | / | / | / | / 17-orphan
x / | / | / | / | / | / | / 171-similarity
x / | / | / | / | / | / | / | / similarity-var.pdf (8Kb)
x / | / | / | / | / | / | / 172-market-exclusivity
x / | / | / | / | / | / | / | / marketexclusivity-var.pdf (8Kb)
x / | / | / | / | / | / 18-pharmacovigilance
x / | / | / | / | / | / | / 181-phvig-system
x / | / | / | / | / | / | / | / phvigsystem-var.pdf (8Kb)
x / | / | / | / | / | / | / 182-riskmgt-system
x / | / | / | / | / | / | / | / riskmgtsystem-var.pdf (8Kb)
x / | / | / | / | / | / 19-clinical-trials
x / | / | / | / | / | / | / clinicaltrials-var.pdf (8Kb)
x / | / | / | / | / | / additional-data
x / | / | / | / | / | / | / be
x / | / | / | / | / | / | / | / be-additionaldata-var.pdf (8Kb)
x / | / | / | / | / | / responses
x / | / | / | / | / | / | / be
x / | / | / | / | / | / | / | / be-responses-var.pdf (8Kb)
x / M / | / | / | / m2
x / | / | / | / | / 22-intro
x / | / | / | / | / | / introduction-var.pdf (8Kb)
x / | / | / | / | / 23-qos
x / | / | / | / | / | / appendices-var.pdf (8Kb)
x / | / | / | / | / | / drug-product-var.pdf (8Kb)
x / | / | / | / | / | / drug-substance-var.pdf (8Kb)
x / | / | / | / | / | / introduction-var.pdf (8Kb)
x / | / | / | / | / | / regional-information-var.pdf (8Kb)
x / | / | / | / | / 24-nonclin-over
x / | / | / | / | / | / nonclinical-overview-var.pdf (8Kb)
x / | / | / | / | / 25-clin-over
x / | / | / | / | / | / clinical-overview-var.pdf (8Kb)
x / | / | / | / | / 26-nonclin-sum
x / | / | / | / | / | / introduction-var.pdf (8Kb)
x / | / | / | / | / | / pharmacol-tabulated-summary-var.pdf (8Kb)
x / | / | / | / | / | / pharmacol-written-summary-var.pdf (8Kb)
x / | / | / | / | / | / pharmkin-tabulated-summary-var.pdf (8Kb)
x / | / | / | / | / | / pharmkin-written-summary-var.pdf (8Kb)
x / | / | / | / | / | / toxicology-tabulated-summary-var.pdf (8Kb)
x / | / | / | / | / | / toxicology-written-summary-var.pdf (8Kb)
x / | / | / | / | / 27-clin-sum
x / | / | / | / | / | / literature-references-var.pdf (8Kb)
x / | / | / | / | / | / summary-biopharm-var.pdf (8Kb)
x / | / | / | / | / | / summary-clin-efficacy-var.pdf (8Kb)
x / | / | / | / | / | / summary-clin-pharm-var.pdf (8Kb)
x / | / | / | / | / | / summary-clin-safety-var.pdf (8Kb)
x / | / | / | / | / | / synopses-indiv-studies-var.pdf (8Kb)
x / M / | / | / | / m3
x / | / | / | / | / 32-body-data
x / | / | / | / | / | / 32a-app
x / | / | / | / | / | / | / 32a1-fac-equip
x / | / | / | / | / | / | / | / facilities-and-equipment-report.pdf (8Kb)
x / | / | / | / | / | / | / 32a2-advent-agent
x / | / | / | / | / | / | / | / adventitious-agents-report.pdf (8Kb)
x / | / | / | / | / | / | / 32a3-excip-substance
x / | / | / | / | / | / | / | / substance.pdf (8Kb)
x / | / | / | / | / | / 32p-drug-prod
x / | / | / | / | / | / | / drug-product
x / | / | / | / | / | / | / | / 32p1-desc-comp
x / | / | / | / | / | / | / | / | / description-and-composition-var.pdf (8Kb)
x / | / | / | / | / | / | / | / 32p2-pharm-dev
x / | / | / | / | / | / | / | / | / pharmaceutical-development-var.pdf (8Kb)
x / | / | / | / | / | / | / | / 32p3-manuf
x / | / | / | / | / | / | / | / | / batch-formula-var.pdf (8Kb)
x / | / | / | / | / | / | / | / | / control-critical-steps-var.pdf (8Kb)
x / | / | / | / | / | / | / | / | / manuf-process-and-controls-var.pdf (8Kb)
x / | / | / | / | / | / | / | / | / manufacturers-var.pdf (8Kb)
x / | / | / | / | / | / | / | / | / process-validation-var.pdf (8Kb)
x / | / | / | / | / | / | / | / 32p4-contr-excip
x / | / | / | / | / | / | / | / | / compendial-leaflets
x / | / | / | / | / | / | / | / | / | / analytical-procedures.pdf (8Kb)
x / | / | / | / | / | / | / | / | / | / excipients-human-animal-var.pdf (8Kb)
x / | / | / | / | / | / | / | / | / | / justification-of-specifications.pdf (8Kb)
x / | / | / | / | / | / | / | / | / | / novel-excipients-var.pdf (8Kb)
x / | / | / | / | / | / | / | / | / | / specifications.pdf (8Kb)
x / | / | / | / | / | / | / | / | / | / validation-analyt-procedures.pdf (8Kb)
x / | / | / | / | / | / | / | / | / excipient
x / | / | / | / | / | / | / | / | / | / analytical-procedures-var.pdf (8Kb)
x / | / | / | / | / | / | / | / | / | / justification-of-specifications-var.pdf (8Kb)
x / | / | / | / | / | / | / | / | / | / specifications-var.pdf (8Kb)
x / | / | / | / | / | / | / | / | / | / validation-analyt-procedures-var.pdf (8Kb)
x / | / | / | / | / | / | / | / 32p5-contr-drug-prod
x / | / | / | / | / | / | / | / | / 32p51-spec
x / | / | / | / | / | / | / | / | / | / specifications-var.pdf (8Kb)
x / | / | / | / | / | / | / | / | / 32p52-analyt-proc
x / | / | / | / | / | / | / | / | / | / analytical-procedure.pdf (8Kb)
x / | / | / | / | / | / | / | / | / 32p53-val-analyt-proc
x / | / | / | / | / | / | / | / | / | / validation-analytical-procedures.pdf (8Kb)
x / | / | / | / | / | / | / | / | / 32p54-batch-analys
x / | / | / | / | / | / | / | / | / | / batch-analyses-var.pdf (8Kb)
x / | / | / | / | / | / | / | / | / 32p55-charac-imp
x / | / | / | / | / | / | / | / | / | / characterisation-impurities-var.pdf (8Kb)
x / | / | / | / | / | / | / | / | / 32p56-justif-spec
x / | / | / | / | / | / | / | / | / | / justification-of-specifications-var.pdf (8Kb)
x / | / | / | / | / | / | / | / 32p6-ref-stand
x / | / | / | / | / | / | / | / | / reference-standards-var.pdf (8Kb)
x / | / | / | / | / | / | / | / 32p7-cont-closure-sys
x / | / | / | / | / | / | / | / | / container-closure-system-var.pdf (8Kb)
x / | / | / | / | / | / | / | / 32p8-stab
x / | / | / | / | / | / | / | / | / postapproval-stability-var.pdf (8Kb)
x / | / | / | / | / | / | / | / | / stability-data-var.pdf (8Kb)
x / | / | / | / | / | / | / | / | / stability-summary-var.pdf (8Kb)
x / | / | / | / | / | / 32r-reg-info
x / | / | / | / | / | / | / certificate-suitability.pdf (8Kb)
x / | / | / | / | / | / | / materials-animal-human-origin.pdf (8Kb)
x / | / | / | / | / | / | / medical-device.pdf (8Kb)
x / | / | / | / | / | / | / process-val-scheme.pdf (8Kb)
x / | / | / | / | / | / 32s-drug-sub
x / | / | / | / | / | / | / drug-substance
x / | / | / | / | / | / | / | / 32s1-gen-info
x / | / | / | / | / | / | / | / | / general-properties-var.pdf (8Kb)
x / | / | / | / | / | / | / | / | / nomenclature-var.pdf (8Kb)
x / | / | / | / | / | / | / | / | / structure-var.pdf (8Kb)
x / | / | / | / | / | / | / | / 32s2-manuf
x / | / | / | / | / | / | / | / | / control-critical-steps-var.pdf (8Kb)
x / | / | / | / | / | / | / | / | / control-of-materials-var.pdf (8Kb)
x / | / | / | / | / | / | / | / | / manuf-process-and-controls-var.pdf (8Kb)
x / | / | / | / | / | / | / | / | / manuf-process-development-var.pdf (8Kb)
x / | / | / | / | / | / | / | / | / manufacturer-var.pdf (8Kb)
x / | / | / | / | / | / | / | / | / process-validation-var.pdf (8Kb)
x / | / | / | / | / | / | / | / 32s3-charac
x / | / | / | / | / | / | / | / | / elucidation-of-structure-var.pdf (8Kb)
x / | / | / | / | / | / | / | / | / impurities-var.pdf (8Kb)
x / | / | / | / | / | / | / | / 32s4-contr-drug-sub
x / | / | / | / | / | / | / | / | / 32s41-spec
x / | / | / | / | / | / | / | / | / | / specification-var.pdf (8Kb)
x / | / | / | / | / | / | / | / | / 32s42-analyt-proc
x / | / | / | / | / | / | / | / | / | / analytical-procedure.pdf (8Kb)
x / | / | / | / | / | / | / | / | / 32s43-val-analyt-proc
x / | / | / | / | / | / | / | / | / | / validation-analyt-procedure.pdf (8Kb)
x / | / | / | / | / | / | / | / | / 32s44-batch-analys
x / | / | / | / | / | / | / | / | / | / batch-analyses-var.pdf (8Kb)
x / | / | / | / | / | / | / | / | / 32s45-justif-spec
x / | / | / | / | / | / | / | / | / | / justification-of-specification-var.pdf (8Kb)
x / | / | / | / | / | / | / | / 32s5-ref-stand
x / | / | / | / | / | / | / | / | / reference-standards-var.pdf (8Kb)
x / | / | / | / | / | / | / | / 32s6-cont-closure-sys
x / | / | / | / | / | / | / | / | / container-closure-system-var.pdf (8Kb)
x / | / | / | / | / | / | / | / 32s7-stab
x / | / | / | / | / | / | / | / | / postapproval-stability-var.pdf (8Kb)
x / | / | / | / | / | / | / | / | / stability-data-var.pdf (8Kb)
x / | / | / | / | / | / | / | / | / stability-summary-var.pdf (8Kb)
x / | / | / | / | / 33-lit-ref
x / | / | / | / | / | / reference.pdf (8Kb)
x / M / | / | / | / m4
x / | / | / | / | / 42-stud-rep
x / | / | / | / | / | / 421-pharmacol
x / | / | / | / | / | / | / 4211-prim-pd
x / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / | / 4212-sec-pd
x / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / | / 4213-safety-pharmacol
x / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / | / 4214-pd-drug-interact
x / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / 422-pk
x / | / | / | / | / | / | / 4221-analyt-met-val
x / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / | / 4222-absorp
x / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / | / 4223-distrib
x / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / | / 4224-metab
x / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / | / 4225-excr
x / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / | / 4226-pk-drug-interact
x / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / | / 4227-other-pk-stud
x / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / 423-tox
x / | / | / | / | / | / | / 4231-single-dose-tox
x / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / | / 4232-repeat-dose-tox
x / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / | / 4233-genotox
x / | / | / | / | / | / | / | / 42331-in-vitro
x / | / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / | / | / 42332-in-vivo
x / | / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / | / 4234-carcigen
x / | / | / | / | / | / | / | / 42341-lt-stud
x / | / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / | / | / 42342-smt-stud
x / | / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / | / | / 42343-other-stud
x / | / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / | / 4235-repro-dev-tox
x / | / | / | / | / | / | / | / 42351-fert-embryo-dev
x / | / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / | / | / 42352-embryo-fetal-dev
x / | / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / | / | / 42353-pre-postnatal-dev
x / | / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / | / | / 42354-juv
x / | / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / | / 4236-loc-tol
x / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / | / 4237-other-tox-stud
x / | / | / | / | / | / | / | / 42371-antigen
x / | / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / | / | / 42372-immunotox
x / | / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / | / | / 42373-mechan-stud
x / | / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / | / | / 42374-dep
x / | / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / | / | / 42375-metab
x / | / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / | / | / 42376-imp
x / | / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / | / | / 42377-other
x / | / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / 43-lit-ref
x / | / | / | / | / | / reference.pdf (8Kb)
x / M / | / | / | / m5
x / | / | / | / | / 52-tab-list
x / | / | / | / | / | / tabular-listing-var.pdf (8Kb)
x / | / | / | / | / 53-clin-stud-rep
x / | / | / | / | / | / 531-rep-biopharm-stud
x / | / | / | / | / | / | / 5311-ba-stud-rep
x / | / | / | / | / | / | / | / study-report
x / | / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / | / 5312-compar-ba-be-stud-rep
x / | / | / | / | / | / | / | / study-report
x / | / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / | / 5313-in-vitro-in-vivo-corr-stud-rep
x / | / | / | / | / | / | / | / study-report
x / | / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / | / 5314-bioanalyt-analyt-met
x / | / | / | / | / | / | / | / study-report
x / | / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / 532-rep-stud-pk-human-biomat
x / | / | / | / | / | / | / 5321-plasma-prot-bind-stud-rep
x / | / | / | / | / | / | / | / study-report
x / | / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / | / 5322-rep-hep-metab-interact-stud
x / | / | / | / | / | / | / | / study-report
x / | / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / | / 5323-stud-other-human-biomat
x / | / | / | / | / | / | / | / study-report
x / | / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / 533-rep-human-pk-stud
x / | / | / | / | / | / | / 5331-healthy-subj-pk-init-tol-stud-rep
x / | / | / | / | / | / | / | / study-report
x / | / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / | / 5332-patient-pk-init-tol-stud-rep
x / | / | / | / | / | / | / | / study-report
x / | / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / | / 5333-intrin-factor-pk-stud-rep
x / | / | / | / | / | / | / | / study-report
x / | / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / | / 5334-extrin-factor-pk-stud-rep
x / | / | / | / | / | / | / | / study-report
x / | / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / | / 5335-popul-pk-stud-rep
x / | / | / | / | / | / | / | / study-report
x / | / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / 534-rep-human-pd-stud
x / | / | / | / | / | / | / 5341-healthy-subj-pd-stud-rep
x / | / | / | / | / | / | / | / study-report
x / | / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / | / 5342-patient-pd-stud-rep
x / | / | / | / | / | / | / | / study-report
x / | / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / 535-rep-effic-safety-stud
x / | / | / | / | / | / | / indication
x / | / | / | / | / | / | / | / 5351-stud-rep-contr
x / | / | / | / | / | / | / | / | / study-report
x / | / | / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / | / | / 5352-stud-rep-uncontr
x / | / | / | / | / | / | / | / | / study-report
x / | / | / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / | / | / 5353-rep-analys-data-more-one-stud
x / | / | / | / | / | / | / | / | / study-report
x / | / | / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / | / | / 5354-other-stud-rep
x / | / | / | / | / | / | / | / | / study-report
x / | / | / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / 536-postmark-exp
x / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / 537-crf-ipl
x / | / | / | / | / | / | / study
x / | / | / | / | / | / | / | / filename.pdf (8Kb)
x / | / | / | / | / 54-lit-ref
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| / FR-H-1234-01
x / M / | / | / 0000
x / M / | / | / | / m1
x / | / | / | / | / eu
x / | / | / | / | / | / 10-cover
x / | / | / | / | / | / | / be
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x / | / | / | / | / | / 110-paediatrics
x / | / | / | / | / | / | / paediatrics-var.pdf (8Kb)
x / | / | / | / | / | / 12-form
x / | / | / | / | / | / | / be
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x / | / | / | / | / | / 13-pi
x / | / | / | / | / | / | / 131-spclabelpl
x / | / | / | / | / | / | / | / be
x / | / | / | / | / | / | / | / | / de
x / | / | / | / | / | / | / | / | / | / be-impack-10mgdec06.pdf (7Kb)
x / | / | / | / | / | / | / | / | / | / be-interpack-10mgdec06.pdf (7Kb)
x / | / | / | / | / | / | / | / | / | / be-outer-10mgdec06.pdf (7Kb)
x / | / | / | / | / | / | / | / | / | / be-pl-10mgdec06.pdf (7Kb)
x / | / | / | / | / | / | / | / | / fr
x / | / | / | / | / | / | / | / | / | / be-impack-10mgdec06.pdf (7Kb)
x / | / | / | / | / | / | / | / | / | / be-interpack-10mgdec06.pdf (7Kb)
x / | / | / | / | / | / | / | / | / | / be-outer-10mgdec06.pdf (7Kb)
x / | / | / | / | / | / | / | / | / | / be-pl-10mgdec06.pdf (7Kb)
x / | / | / | / | / | / | / | / | / | / be-spc-combineddec06.pdf (7Kb)
x / | / | / | / | / | / | / | / | / nl
x / | / | / | / | / | / | / | / | / | / be-impack-10mgdec06.pdf (7Kb)
x / | / | / | / | / | / | / | / | / | / be-interpack-10mgdec06.pdf (7Kb)
x / | / | / | / | / | / | / | / | / | / be-outer-10mgdec06.pdf (7Kb)
x / | / | / | / | / | / | / | / | / | / be-pl-10mgdec06.pdf (7Kb)
x / | / | / | / | / | / | / | / | / | / be-spc-combineddec06.pdf (7Kb)
x / | / | / | / | / | / | / | / common
x / | / | / | / | / | / | / | / | / en
x / | / | / | / | / | / | / | / | / | / common-impack-10mgdec06.pdf (7Kb)
x / | / | / | / | / | / | / | / | / | / common-interpack-10mgdec06.pdf (7Kb)
x / | / | / | / | / | / | / | / | / | / common-outer-10mgdec06.pdf (7Kb)
x / | / | / | / | / | / | / | / | / | / common-pl-10mgdec06.pdf (7Kb)
x / | / | / | / | / | / | / | / | / | / common-spc-combineddec06.pdf (7Kb)
x / | / | / | / | / | / | / 132-mockup
x / | / | / | / | / | / | / | / be
x / | / | / | / | / | / | / | / | / be-mockup-var.pdf (8Kb)
x / | / | / | / | / | / | / 133-specimen
x / | / | / | / | / | / | / | / be
x / | / | / | / | / | / | / | / | / be-specimen-var.pdf (8Kb)
x / | / | / | / | / | / | / 134-consultation
x / | / | / | / | / | / | / | / be
x / | / | / | / | / | / | / | / | / be-consultation-var.pdf (8Kb)
x / | / | / | / | / | / | / 135-approved
x / | / | / | / | / | / | / | / be
x / | / | / | / | / | / | / | / | / be-approved-var.pdf (8Kb)
x / | / | / | / | / | / | / 136-braille
x / | / | / | / | / | / | / | / braille-var.pdf (8Kb)
x / | / | / | / | / | / 14-expert
x / | / | / | / | / | / | / 141-quality
x / | / | / | / | / | / | / | / quality-var.pdf (8Kb)
x / | / | / | / | / | / | / 142-nonclinical
x / | / | / | / | / | / | / | / nonclinical-var.pdf (8Kb)
x / | / | / | / | / | / | / 143-clinical
x / | / | / | / | / | / | / | / clinical-var.pdf (8Kb)
x / | / | / | / | / | / 15-specific
x / | / | / | / | / | / | / 151-bibliographic
x / | / | / | / | / | / | / | / bibliographic-var.pdf (8Kb)
x / | / | / | / | / | / | / 152-generic-hybrid-bio-similar
x / | / | / | / | / | / | / | / biosimilar-var.pdf (8Kb)
x / | / | / | / | / | / | / | / generic-var.pdf (8Kb)
x / | / | / | / | / | / | / | / hybrid-var.pdf (8Kb)
x / | / | / | / | / | / | / 153-data-market-exclusivity
x / | / | / | / | / | / | / | / datamarketexclusivity-var.pdf (8Kb)
x / | / | / | / | / | / | / 154-exceptional
x / | / | / | / | / | / | / | / exceptional-var.pdf (8Kb)
x / | / | / | / | / | / | / 155-conditional-ma
x / | / | / | / | / | / | / | / conditionalma-var.pdf (8Kb)
x / | / | / | / | / | / 16-environrisk
x / | / | / | / | / | / | / 161-nongmo
x / | / | / | / | / | / | / | / nongmo-var.pdf (8Kb)
x / | / | / | / | / | / | / 162-gmo
x / | / | / | / | / | / | / | / gmo-var.pdf (8Kb)
x / | / | / | / | / | / 17-orphan
x / | / | / | / | / | / | / 171-similarity
x / | / | / | / | / | / | / | / similarity-var.pdf (8Kb)
x / | / | / | / | / | / | / 172-market-exclusivity
x / | / | / | / | / | / | / | / marketexclusivity-var.pdf (8Kb)
x / | / | / | / | / | / 18-pharmacovigilance
x / | / | / | / | / | / | / 181-phvig-system
x / | / | / | / | / | / | / | / phvigsystem-var.pdf (8Kb)
x / | / | / | / | / | / | / 182-riskmgt-system
x / | / | / | / | / | / | / | / riskmgtsystem-var.pdf (8Kb)
x / | / | / | / | / | / 19-clinical-trials
x / | / | / | / | / | / | / clinicaltrials-var.pdf (8Kb)
x / | / | / | / | / | / additional-data
x / | / | / | / | / | / | / be
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x / | / | / | / | / | / responses
x / | / | / | / | / | / | / be
x / | / | / | / | / | / | / | / be-responses-var.pdf (8Kb)
x / M / | / | / | / m2
x / | / | / | / | / 22-intro
x / | / | / | / | / | / introduction-var.pdf (8Kb)
x / | / | / | / | / 23-qos
x / | / | / | / | / | / appendices-var.pdf (8Kb)
x / | / | / | / | / | / drug-product-var.pdf (8Kb)
x / | / | / | / | / | / drug-substance-var.pdf (8Kb)
x / | / | / | / | / | / introduction-var.pdf (8Kb)
x / | / | / | / | / | / regional-information-var.pdf (8Kb)
x / | / | / | / | / 24-nonclin-over
x / | / | / | / | / | / nonclinical-overview-var.pdf (8Kb)
x / | / | / | / | / 25-clin-over
x / | / | / | / | / | / clinical-overview-var.pdf (8Kb)
x / | / | / | / | / 26-nonclin-sum
x / | / | / | / | / | / introduction-var.pdf (8Kb)
x / | / | / | / | / | / pharmacol-tabulated-summary-var.pdf (8Kb)
x / | / | / | / | / | / pharmacol-written-summary-var.pdf (8Kb)
x / | / | / | / | / | / pharmkin-tabulated-summary-var.pdf (8Kb)
x / | / | / | / | / | / pharmkin-written-summary-var.pdf (8Kb)
x / | / | / | / | / | / toxicology-tabulated-summary-var.pdf (8Kb)
x / | / | / | / | / | / toxicology-written-summary-var.pdf (8Kb)
x / | / | / | / | / 27-clin-sum
x / | / | / | / | / | / literature-references-var.pdf (8Kb)
x / | / | / | / | / | / summary-biopharm-var.pdf (8Kb)
x / | / | / | / | / | / summary-clin-efficacy-var.pdf (8Kb)
x / | / | / | / | / | / summary-clin-pharm-var.pdf (8Kb)
x / | / | / | / | / | / summary-clin-safety-var.pdf (8Kb)
x / | / | / | / | / | / synopses-indiv-studies-var.pdf (8Kb)
x / M / | / | / | / m3
x / | / | / | / | / 32-body-data
x / | / | / | / | / | / 32a-app
x / | / | / | / | / | / | / 32a1-fac-equip
x / | / | / | / | / | / | / | / facilities-and-equipment-report.pdf (8Kb)
x / | / | / | / | / | / | / 32a2-advent-agent
x / | / | / | / | / | / | / | / adventitious-agents-report.pdf (8Kb)
x / | / | / | / | / | / | / 32a3-excip-substance
x / | / | / | / | / | / | / | / substance.pdf (8Kb)
x / | / | / | / | / | / 32p-drug-prod
x / | / | / | / | / | / | / drug-product
x / | / | / | / | / | / | / | / 32p1-desc-comp
x / | / | / | / | / | / | / | / | / description-and-composition-var.pdf (8Kb)
x / | / | / | / | / | / | / | / 32p2-pharm-dev
x / | / | / | / | / | / | / | / | / pharmaceutical-development-var.pdf (8Kb)
x / | / | / | / | / | / | / | / 32p3-manuf
x / | / | / | / | / | / | / | / | / batch-formula-var.pdf (8Kb)
x / | / | / | / | / | / | / | / | / control-critical-steps-var.pdf (8Kb)
x / | / | / | / | / | / | / | / | / manuf-process-and-controls-var.pdf (8Kb)
x / | / | / | / | / | / | / | / | / manufacturers-var.pdf (8Kb)
x / | / | / | / | / | / | / | / | / process-validation-var.pdf (8Kb)
x / | / | / | / | / | / | / | / 32p4-contr-excip
x / | / | / | / | / | / | / | / | / compendial-leaflets
x / | / | / | / | / | / | / | / | / | / analytical-procedures.pdf (8Kb)
x / | / | / | / | / | / | / | / | / | / excipients-human-animal-var.pdf (8Kb)
x / | / | / | / | / | / | / | / | / | / justification-of-specifications.pdf (8Kb)
x / | / | / | / | / | / | / | / | / | / novel-excipients-var.pdf (8Kb)
x / | / | / | / | / | / | / | / | / | / specifications.pdf (8Kb)
x / | / | / | / | / | / | / | / | / | / validation-analyt-procedures.pdf (8Kb)
x / | / | / | / | / | / | / | / | / excipient
x / | / | / | / | / | / | / | / | / | / analytical-procedures-var.pdf (8Kb)
x / | / | / | / | / | / | / | / | / | / justification-of-specifications-var.pdf (8Kb)
x / | / | / | / | / | / | / | / | / | / specifications-var.pdf (8Kb)
x / | / | / | / | / | / | / | / | / | / validation-analyt-procedures-var.pdf (8Kb)
x / | / | / | / | / | / | / | / 32p5-contr-drug-prod
x / | / | / | / | / | / | / | / | / 32p51-spec
x / | / | / | / | / | / | / | / | / | / specifications-var.pdf (8Kb)
x / | / | / | / | / | / | / | / | / 32p52-analyt-proc
x / | / | / | / | / | / | / | / | / | / analytical-procedure.pdf (8Kb)
x / | / | / | / | / | / | / | / | / 32p53-val-analyt-proc
x / | / | / | / | / | / | / | / | / | / validation-analytical-procedures.pdf (8Kb)
x / | / | / | / | / | / | / | / | / 32p54-batch-analys
x / | / | / | / | / | / | / | / | / | / batch-analyses-var.pdf (8Kb)
x / | / | / | / | / | / | / | / | / 32p55-charac-imp
x / | / | / | / | / | / | / | / | / | / characterisation-impurities-var.pdf (8Kb)
x / | / | / | / | / | / | / | / | / 32p56-justif-spec
x / | / | / | / | / | / | / | / | / | / justification-of-specifications-var.pdf (8Kb)
x / | / | / | / | / | / | / | / 32p6-ref-stand
x / | / | / | / | / | / | / | / | / reference-standards-var.pdf (8Kb)
x / | / | / | / | / | / | / | / 32p7-cont-closure-sys
x / | / | / | / | / | / | / | / | / container-closure-system-var.pdf (8Kb)
x / | / | / | / | / | / | / | / 32p8-stab
x / | / | / | / | / | / | / | / | / postapproval-stability-var.pdf (8Kb)
x / | / | / | / | / | / | / | / | / stability-data-var.pdf (8Kb)
x / | / | / | / | / | / | / | / | / stability-summary-var.pdf (8Kb)
x / | / | / | / | / | / 32r-reg-info
x / | / | / | / | / | / | / certificate-suitability.pdf (8Kb)
x / | / | / | / | / | / | / materials-animal-human-origin.pdf (8Kb)
x / | / | / | / | / | / | / medical-device.pdf (8Kb)
x / | / | / | / | / | / | / process-val-scheme.pdf (8Kb)
x / | / | / | / | / | / 32s-drug-sub
x / | / | / | / | / | / | / drug-substance
x / | / | / | / | / | / | / | / 32s1-gen-info
x / | / | / | / | / | / | / | / | / general-properties-var.pdf (8Kb)
x / | / | / | / | / | / | / | / | / nomenclature-var.pdf (8Kb)
x / | / | / | / | / | / | / | / | / structure-var.pdf (8Kb)
x / | / | / | / | / | / | / | / 32s2-manuf
x / | / | / | / | / | / | / | / | / control-critical-steps-var.pdf (8Kb)
x / | / | / | / | / | / | / | / | / control-of-materials-var.pdf (8Kb)
x / | / | / | / | / | / | / | / | / manuf-process-and-controls-var.pdf (8Kb)
x / | / | / | / | / | / | / | / | / manuf-process-development-var.pdf (8Kb)
x / | / | / | / | / | / | / | / | / manufacturer-var.pdf (8Kb)
x / | / | / | / | / | / | / | / | / process-validation-var.pdf (8Kb)
x / | / | / | / | / | / | / | / 32s3-charac
x / | / | / | / | / | / | / | / | / elucidation-of-structure-var.pdf (8Kb)
x / | / | / | / | / | / | / | / | / impurities-var.pdf (8Kb)
x / | / | / | / | / | / | / | / 32s4-contr-drug-sub
x / | / | / | / | / | / | / | / | / 32s41-spec
x / | / | / | / | / | / | / | / | / | / specification-var.pdf (8Kb)
x / | / | / | / | / | / | / | / | / 32s42-analyt-proc
x / | / | / | / | / | / | / | / | / | / analytical-procedure.pdf (8Kb)
x / | / | / | / | / | / | / | / | / 32s43-val-analyt-proc
x / | / | / | / | / | / | / | / | / | / validation-analyt-procedure.pdf (8Kb)
x / | / | / | / | / | / | / | / | / 32s44-batch-analys
x / | / | / | / | / | / | / | / | / | / batch-analyses-var.pdf (8Kb)
x / | / | / | / | / | / | / | / | / 32s45-justif-spec
x / | / | / | / | / | / | / | / | / | / justification-of-specification-var.pdf (8Kb)
x / | / | / | / | / | / | / | / 32s5-ref-stand
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x / | / | / | / | / | / | / | / | / container-closure-system-var.pdf (8Kb)
x / | / | / | / | / | / | / | / 32s7-stab
x / | / | / | / | / | / | / | / | / postapproval-stability-var.pdf (8Kb)
x / | / | / | / | / | / | / | / | / stability-data-var.pdf (8Kb)
x / | / | / | / | / | / | / | / | / stability-summary-var.pdf (8Kb)
x / | / | / | / | / 33-lit-ref
x / | / | / | / | / | / reference.pdf (8Kb)
x / M / | / | / | / m4
x / | / | / | / | / 42-stud-rep
x / | / | / | / | / | / 421-pharmacol
x / | / | / | / | / | / | / 4211-prim-pd
x / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / | / 4212-sec-pd
x / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / | / 4213-safety-pharmacol
x / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / | / 4214-pd-drug-interact
x / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / 422-pk
x / | / | / | / | / | / | / 4221-analyt-met-val
x / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / | / 4222-absorp
x / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / | / 4223-distrib
x / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / | / 4224-metab
x / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / | / 4225-excr
x / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / | / 4226-pk-drug-interact
x / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / | / 4227-other-pk-stud
x / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / 423-tox
x / | / | / | / | / | / | / 4231-single-dose-tox
x / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / | / 4232-repeat-dose-tox
x / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / | / 4233-genotox
x / | / | / | / | / | / | / | / 42331-in-vitro
x / | / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / | / | / 42332-in-vivo
x / | / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / | / 4234-carcigen
x / | / | / | / | / | / | / | / 42341-lt-stud
x / | / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / | / | / 42342-smt-stud
x / | / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / | / | / 42343-other-stud
x / | / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / | / 4235-repro-dev-tox
x / | / | / | / | / | / | / | / 42351-fert-embryo-dev
x / | / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / | / | / 42352-embryo-fetal-dev
x / | / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / | / | / 42353-pre-postnatal-dev
x / | / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / | / | / 42354-juv
x / | / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / | / 4236-loc-tol
x / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / | / 4237-other-tox-stud
x / | / | / | / | / | / | / | / 42371-antigen
x / | / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / | / | / 42372-immunotox
x / | / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / | / | / 42373-mechan-stud
x / | / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / | / | / 42374-dep
x / | / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / | / | / 42375-metab
x / | / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / | / | / 42376-imp
x / | / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / | / | / 42377-other
x / | / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / 43-lit-ref
x / | / | / | / | / | / reference.pdf (8Kb)
x / M / | / | / | / m5
x / | / | / | / | / 52-tab-list
x / | / | / | / | / | / tabular-listing-var.pdf (8Kb)
x / | / | / | / | / 53-clin-stud-rep
x / | / | / | / | / | / 531-rep-biopharm-stud
x / | / | / | / | / | / | / 5311-ba-stud-rep
x / | / | / | / | / | / | / | / study-report
x / | / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / | / 5312-compar-ba-be-stud-rep
x / | / | / | / | / | / | / | / study-report
x / | / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / | / 5313-in-vitro-in-vivo-corr-stud-rep
x / | / | / | / | / | / | / | / study-report
x / | / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / | / 5314-bioanalyt-analyt-met
x / | / | / | / | / | / | / | / study-report
x / | / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / 532-rep-stud-pk-human-biomat
x / | / | / | / | / | / | / 5321-plasma-prot-bind-stud-rep
x / | / | / | / | / | / | / | / study-report
x / | / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / | / 5322-rep-hep-metab-interact-stud
x / | / | / | / | / | / | / | / study-report
x / | / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / | / 5323-stud-other-human-biomat
x / | / | / | / | / | / | / | / study-report
x / | / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / 533-rep-human-pk-stud
x / | / | / | / | / | / | / 5331-healthy-subj-pk-init-tol-stud-rep
x / | / | / | / | / | / | / | / study-report
x / | / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / | / 5332-patient-pk-init-tol-stud-rep
x / | / | / | / | / | / | / | / study-report
x / | / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / | / 5333-intrin-factor-pk-stud-rep
x / | / | / | / | / | / | / | / study-report
x / | / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / | / 5334-extrin-factor-pk-stud-rep
x / | / | / | / | / | / | / | / study-report
x / | / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / | / 5335-popul-pk-stud-rep
x / | / | / | / | / | / | / | / study-report
x / | / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / 534-rep-human-pd-stud
x / | / | / | / | / | / | / 5341-healthy-subj-pd-stud-rep
x / | / | / | / | / | / | / | / study-report
x / | / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / | / 5342-patient-pd-stud-rep
x / | / | / | / | / | / | / | / study-report
x / | / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / 535-rep-effic-safety-stud
x / | / | / | / | / | / | / indication
x / | / | / | / | / | / | / | / 5351-stud-rep-contr
x / | / | / | / | / | / | / | / | / study-report
x / | / | / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / | / | / 5352-stud-rep-uncontr
x / | / | / | / | / | / | / | / | / study-report
x / | / | / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / | / | / 5353-rep-analys-data-more-one-stud
x / | / | / | / | / | / | / | / | / study-report
x / | / | / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / | / | / 5354-other-stud-rep
x / | / | / | / | / | / | / | / | / study-report
x / | / | / | / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / 536-postmark-exp
x / | / | / | / | / | / | / study-report.pdf (8Kb)
x / | / | / | / | / | / 537-crf-ipl
x / | / | / | / | / | / | / study
x / | / | / | / | / | / | / | / filename.pdf (8Kb)
x / | / | / | / | / 54-lit-ref
x / | / | / | / | / | / reference.pdf (8Kb)

Number of files: 354
Number of subfolder: 370

Number of subfolders that are not NeeS-folders: 0 (= 0.00%)
Number of subfolders that contains files and shouldn't: 0 (= 0.00%)
==> Folder score: 371/371 (= 100.00%)

Number of files with wrong name: 0 (= 0.00%)
Number of files with wrong extension: 0 (= 0.00%)
Number of files that could not be checked correctly (because they are in a non-NeeS-folder: 0 (= 0.00%)
==> File score: 354/354 (100.00%)

Other Criteria:
Password encrypted to open : 0
Path length error : 0
PDF file version : 0
PDF file is not valid : 0

x / Document or Folder completely OK
x / Folder can not contain files
x / Name contains illegal characters (only lower cases, digitis and '-' allowed)
x / Name not conform NeeS guideline
x / Document has an extension that is not allowed
x / Document can not be checked correctly because it is in a non-NeeS-folder
M / Warning : file missing (ctd-toc.pdf or mx-toc.pdf)
E / Warning : PDF file is password encrypted to open it
L / Warning : Total path length is large (number of characters greater than 180)
x / Error : Total path length is too large (number of characters greater than 230)
V / Error : PDF file version is incorrect
V / Error : PDF file is not valid